Novel design for a phase IIa placebo-controlled, double-blind randomized withdrawal study to evaluate the safety and efficacy of CNV1014802 in patients with trigeminal neuralgia

Trials

Volumn 14, Issue 1, 2013, Pages

  Zakrzewska, Joanna M ^a   Palmer, Joanne ^b   Ettlin, Dominik A ^c   Obermann, Mark ^d   Giblin, Gerard M P ^b   Morisset, Valerie ^b   Tate, Simon ^b   Gunn, Kevin ^b  

^a UNIVERSITY COLLEGE LONDON   (United Kingdom)

^b Convergence Pharmaceuticals Ltd ^*  (United Kingdom)

^c UNIVERSITY OF ZURICH   (Switzerland)

^d UNIVERSITY OF DUISBURG ESSEN   (Germany)

Author keywords

Double blind randomized withdrawal study; Neuropathic pain; Sodium channel blocker; Trigeminal neuralgia

Indexed keywords

CARBAMAZEPINE; CNV 1014802; PARACETAMOL; PLACEBO; SODIUM CHANNEL BLOCKING AGENT; UNCLASSIFIED DRUG;

ADULT; ANALGESIA; ARTICLE; CLINICAL ARTICLE; COGNITION; CONTROLLED STUDY; DAILY LIFE ACTIVITY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EPILEPSY; FACE PAIN; FATIGUE; FEMALE; GENOTYPE; GOLD STANDARD; HUMAN; MALE; MONOTHERAPY; NEURALGIA; NEUROPATHIC PAIN; OPEN STUDY; OUTCOME ASSESSMENT; PAIN ASSESSMENT; PHASE 2 CLINICAL TRIAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; TREATMENT FAILURE; TREATMENT OUTCOME;

DOUBLE-BLIND METHOD; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); PHENYL ETHERS; PROLINE; RESEARCH DESIGN; SODIUM CHANNEL BLOCKERS; TRIGEMINAL NEURALGIA; WITHHOLDING TREATMENT;

EID: 84887916276     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-14-402     Document Type: Article

References (52)

1. Obermann M, Yoon MS, Dommes P, Kuznetsova J, Maschke M, Weimar C, Limmroth V, Diener HC, Katsarava Z. Prevalence of trigeminal autonomic symptoms in migraine: a population-based study. Cephalalgia 2007, 27(6):504-509. 10.1111/j.1468-2982.2007.01316.x, 17428298.
2. Katusic S, Williams DB, Beard CM, Bergstralh EJ, Kurland LT. Epidemiology and clinical features of idiopathic trigeminal neuralgia and glossopharyngeal neuralgia: similarities and differences, Rochester, Minnesota, 1945-1984. Neuroepidemiology 1991, 10(5-6):276-281.
3. van Kleef M, van Genderen WE, Narouze S, Nurmikko TJ, van Zundert J, Geurts JW, Mekhail N. 1. Trigeminal neuralgia. Pain Pract 2009, 9(4):252-259. 10.1111/j.1533-2500.2009.00298.x, 19619267.
4. Koopman JS, Dieleman JP, Huygen FJ, De Mos M, Martin CG, Sturkenboom MC. Incidence of facial pain in the general population. Pain 2009, 147(1-3):122-127.
5. IHS IHS Classification ICHD-111 Beta version. 2013, 33(9):629-808. IHS.
6. Obermann M, Yoon MS, Ese D, Maschke M, Kaube H, Diener HC, Katsarava Z. Impaired trigeminal nociceptive processing in patients with trigeminal neuralgia. Neurology 2007, 69(9):835-841. 10.1212/01.wnl.0000269670.30045.6b, 17724285.
7. Prasad S, Galetta S. Trigeminal neuralgia: historical notes and current concepts. Neurologist 2009, 15(2):87-94. 10.1097/NRL.0b013e3181775ac3, 19276786.
8. Zakrzewska JM. Diagnosis and differential diagnosis of trigeminal neuralgia. Clin J Pain 2002, 18(1):14-21. 10.1097/00002508-200201000-00003, 11803298.
9. Wu CJ, Lian YJ, Zheng YK, Zhang HF, Chen Y, Xie NC, Wang LJ. Botulinum toxin type A for the treatment of trigeminal neuralgia: results from a randomized, double-blind, placebo-controlled trial. Cephalalgia 2012, 32(6):443-450. 10.1177/0333102412441721, 22492424.
10. Rothman KJ, Monson RR. Survival in trigeminal neuralgia. J Chronic Dis 1973, 26(5):303-309. 10.1016/0021-9681(73)90033-7, 4718951.
11. Taylor JC, Brauer S, Espir MLE. Long-term treatment of trigeminal neuralgia. Postgrad Med J 1981, 57:16-18. 10.1136/pgmj.57.663.16, 2424760, 7279817.
12. Beydoun A, Schmidt D, D'Souza D. Oxcarbazepine versus carbamazepine in trigeminal neuralgia : a meta-anlaysis of three double blind comparative trials. [abstract]. Neurol 2002, 58:p02.083.
13. Anonymous The international classification of headache disorders: 2nd edition. Cephalalgia 2004, 24(Suppl 1):9-160. Anonymous.
14. Anon The international classification of headache disorders, 3rd edition (beta version). Cephalalgia 2013, 33(9):629-808. Anon.
15. Cruccu G, Gronseth G, Alksne J, Argoff C, Brainin M, Burchiel K, Nurmikko T, Zakrzewska JM. AAN-EFNS guidelines on trigeminal neuralgia management. Eur J Neurol 2008, 15(10):1013-1028. 10.1111/j.1468-1331.2008.02185.x, 18721143.
16. Obermann M, Yoon MS, Sensen K, Maschke M, Diener HC, Katsarava Z. Efficacy of pregabalin in the treatment of trigeminal neuralgia. Cephalalgia 2008, 28(2):174-181.
17. Wiffen PJ, Derry S, Moore RA, McQuay HJ. Carbamazepine for acute and chronic pain in adults. Cochrane Database Syst Rev 2011, 1:CD005451.
18. Meador KJ. Cognitive and memory effects of the new antiepileptic drugs. Epilepsy Res 2006, 68(1):63-67. 10.1016/j.eplepsyres.2005.09.023, 16377148.
19. Meador KJ, Gevins A, Loring DW, McEvoy LK, Ray PG, Smith ME, Motamedi GK, Evans BM, Baum C. Neuropsychological and neurophysiologic effects of carbamazepine and levetiracetam. Neurology 2007, 69(22):2076-2084. 10.1212/01.wnl.0000281104.55418.60, 18040014.
20. Motamedi GK, Meador KJ. Antiepileptic drugs and memory. Epilepsy Behav 2004, 5(4):435-439. 10.1016/j.yebeh.2004.03.006, 15256178.
21. Moriarty O, McGuire BE, Finn DP. The effect of pain on cognitive function: a review of clinical and preclinical research. Prog Neurobiol 2011, 93(3):385-404. 10.1016/j.pneurobio.2011.01.002, 21216272.
22. Fischer TZ, Waxman SG. Familial pain syndromes from mutations of the NaV1.7 sodium channel. Ann N Y Acad Sci 2010, 1184:196-207. 10.1111/j.1749-6632.2009.05110.x, 20146699.
23. Faber CG, Hoeijmakers JG, Ahn HS, Cheng X, Han C, Choi JS, Estacion M, Lauria G, Vanhoutte EK, Gerrits MM, Dib-Hajj S, Drenth JP, Waxman SG, Merkies IS. Gain of function Nanu1.7 mutations in idiopathic small fiber neuropathy. Ann Neurol 2012, 71(1):26-39. 10.1002/ana.22485, 21698661.
24. Pietrobon D. Insights into migraine mechanisms and CaV2.1 calcium channel function from mouse models of familial hemiplegic migraine. J Physiol 2010, 588(Pt 11):1871-1878. 2901975, 20194127.
25. Moore A, Derry S, Eccleston C, Kalso E. Expect analgesic failure; pursue analgesic success. BMJ 2013, 346:f2690. 10.1136/bmj.f2690, 23645858.
26. Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013, 346:e7586. 10.1136/bmj.e7586, 3541470, 23303884.
27. Jorns TP, Zakrzewska JM. Evidence-based approach to the medical management of trigeminal neuralgia. Br J Neurosurg 2007, 21(3):253-261. 10.1080/02688690701219175, 17612914.
28. Wiffen PJ, Derry S, Moore RA. Lamotrigine for acute and chronic pain. Cochrane Database Syst Rev 2011, 2(2):CD006044.
29. Yang M, Zhou M, He L, Chen N, Zakrzewska JM. Non-antiepileptic drugs for trigeminal neuralgia. Cochrane Database Syst Rev 2011, 1:CD004029.
30. McQuay HJ, Derry S, Moore RA, Poulain P, Legout V. Enriched enrolment with randomised withdrawal (EERW): time for a new look at clinical trial design in chronic pain. Pain 2008, 135(3):217-220. 10.1016/j.pain.2008.01.014, 18258369.
31. Quessy SN. Two-stage enriched enrolment pain trials: a brief review of designs and opportunities for broader application. Pain 2010, 148(1):8-13. 10.1016/j.pain.2009.10.029, 19932934.
32. Jorns TP, Johnston A, Zakrzewska JM. Pilot study to evaluate the efficacy and tolerability of leviteracetam (keppra) in the treatment of patients with trigemional neuralgia. Eur J Neurol 2009, 16:740-744. 10.1111/j.1468-1331.2009.02585.x, 19475723.
33. Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain 2005, 113(1-2):9-19.
34. Zakrzewska JM, Chaudhry Z, Nurmikko TJ, Patton DW, Mullens EL. Lamotrigine (lamictal) in refractory trigeminal neuralgia: results from a double-blind placebo controlled crossover trial. Pain 1997, 73(2):223-230. 10.1016/S0304-3959(97)00104-8, 9415509.
35. Lee JY, Chen HI, Urban C, Hojat A, Church E, Xie SX, Farrar JT. Development of and psychometric testing for the brief pain inventory-facial in patients with facial pain syndromes. J Neurosurg 2010, 113(3):516-523. 10.3171/2010.1.JNS09669, 20151778.
36. Baker GA, Frances P, Middleton E. Initial development, reliability, and validity of a patient-based adverse event scale. Epilepsia 1994, 35(suppl 7):80.
37. Gilliam FG, Fessler AJ, Baker G, Vahle V, Carter J, Attarian H. Systematic screening allows reduction of adverse antiepileptic drug effects: a randomized trial. Neurology 2004, 62(1):23-27. 10.1212/WNL.62.1.23, 14718691.
38. Hays RD, Sherbourne CD, Mazel RM. User's manual for medical outcomes study (MOS) Core Measures of Health-Related Quality of Life 1995, Santa Monica, Rand Corporation MR-162-RC.
39. Stewart AL, Ware JE, Sherbourne CD. Psychological distress/well-being and cognitive functioning measures. Measuring Functioning and Well-being: The Medical Outcomes Study Approach 1992, 102-142. Durham NC: Duke University, Stewart AL, Ware JE.
40. Perucca P, Carter J, Vahle V, Gilliam FG. Adverse antiepileptic drug effects: toward a clinically and neurobiologically relevant taxonomy. Neurology 2009, 72(14):1223-1229. 10.1212/01.wnl.0000345667.45642.61, 2677485, 19349601.
41. Moher D, Jones A, Lepage L. Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. JAMA 2001, 285(15):1992-1995. 10.1001/jama.285.15.1992, 11308436.
42. Gilron I, Booher SL, Rowan JS, Max MB. Topiramate in trigeminal neuralgia: a randomized, placebo-controlled multiple crossover pilot study. Clin Neuropharmacol 2001, 24(2):109-112. 10.1097/00002826-200103000-00009, 11307048.
43. Fletcher B, Gheorghe A, Moore D, Wilson S, Damery S. Improving the recruitment activity of clinicians in randomised controlled trials: a systematic review. BMJ Open 2012, 2(1):e000496. 3253423, 22228729.
44. Ellis PE, Bradley RL, Sandy JR, Deacon SA, Griffiths HS, Atack NE, Moore MB, House KA, Wenger NA, Worth V, Ireland AJ. Do I have enough time? The impact of recruiting patients to a randomised controlled trial at recruiting centres. Br Dent J 2012, 213(9):467-470. 10.1038/sj.bdj.2012.986, 23138807.
45. Lechin F, van der Dijs B, Lechin ME, Amat J, Lechin AE, Cabrera A, Gomez F, Acosta E, Arocha L, Villa S, Jienez V. Pimozide therapy for trigeminal neuralgia. Arch Neurol 1989, 46:960-963. 10.1001/archneur.1989.00520450030015, 2673161.
46. Lindstrom P, Lindblom V. The analgesic effect of tocainide in trigeminal neuralgia. Pain 1987, 28:45-50. 10.1016/0304-3959(87)91058-X, 3103044.
47. Vilming ST, Lyberg T, Latase X. Tizanidine in the management of trigeminal neuralgia. Cephalalgia 1986, 6:181-182. 10.1046/j.1468-2982.1986.0603181.x, 3533272.
48. Shaikh S, Yaacob HB, Abd Rahman RB. Lamotrigine for trigeminal neuralgia: efficacy and safety in comparison with carbamazepine. J Chin Med Assoc 2011, 74(6):243-249. 10.1016/j.jcma.2011.04.002, 21621166.
49. Lemos L, Flores S, Oliveira P, Almeida A. Gabapentin supplemented with ropivacain block of trigger points improves pain control and quality of life in trigeminal neuralgia patients when compared with gabapentin alone. Clin J Pain 2008, 24(1):64-75. 10.1097/AJP.0b013e318158011a, 18180639.
50. Liebel JT, Menger N, Langohr H. Oxcarbazepine in der Behandlung der Trigeminusneuralgie. Nervenheilkd 2001, 20:461-465.
51. Godlee F. Publishing study protocols: making them visible will improve registration, reporting and recruitment. BMC News and Views 2001, 2:4.
52. Mathieu S, Boutron I, Moher D, Altman DG, Ravaud P. Comparison of registered and published primary outcomes in randomized controlled trials. JAMA 2009, 302(9):977-984. 10.1001/jama.2009.1242, 19724045.