A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania With Mixed Features in Bipolar-I Disorder (BALSAM-3)
A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania With Mixed Features in Bipolar-I Disorder (BALSAM-3)
This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I)
The primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.
Inclusion Criteria:
Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):
a. Participants must have completed treatment period of parent study.
De novo participants who did not participate in double-blind placebo-controlled studies:
Exclusion Criteria:
All participants:
1. All participants with a risk for suicidal behavior at baseline as determined by Investigator's clinical assessment or history of suicidal behavior as assessed on C-SSRS.
Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):
1. Discontinuation from any KarXT parent studies.
De novo participants who did not participate in double-blind placebo-controlled studies:
Other protocol-defined Inclusion/Exclusion criteria apply.
Clinical.Trials@bms.com855-907-3286
Garden Grove, California 92845-2506, United States
ABB, Buenos Aires F.D. C1199ABB, Argentina
Pleven, 5800, Bulgaria
Ramat Gan, Central District 5265601, Israel
0585950299
Genova, 16132, Italy
Sakai-shi, Osaka 590-0018, Japan
Karatsu-shi, Saga-ken 847-0031, Japan
0955770711
Bunkyo-ku, Tokyo 113-8431, Japan
+81-(0)3-3813-3111
Bunkyo-ku, Tokyo 1138603, Japan
+81-3-3822-2131
Bialystok, Podlaskie Voivodeship 15-272, Poland
Bucharest, 060222, Romania
Sanpetru /Brasov, 507190, Romania
0040724993329
Skarzhyntsi, Khmelnytskyi Oblast 32120, Ukraine
479-367-2688
501-350-3285
501-221-8681
479-927-3000
714-999-6688
229-815-0219
909-488-9116
424-227-8127
714-799-7799
562-690-2200
909-590-8409
714-289-1100
951300492
310-523-4200
20393257112594
954-375-7794
954-604-3900
305-400-0814
305-246-0001
786-512-4106
305-669-6166
786-831-7303
404-255-6005
404-881-5800
404-537-1281
912-744-0800
312-865-6336
301-251-4702
601-420-5810
314-771-6387
267-981-8911
917-701-7484
513-404-0279
330-493-1118
512-323-2622
972-283-6286
409-331-6040
817-907-7330
214-396-4844
5493516858696
0294331546
0408707842
359888451225
359892444643
+359888227165
00359887801545
+359887422440
3853780732
+38513780678
385951648446
38513430020
28722962
+4538640840
+3612100336
+36 30 604 9696
9447218825
9872655008
9985900005
8250737511
+972545838725
+972506261093
972-8-6401463
972506261544
+972-506262005
0255035982
+39335435387
+390577585409
3498069293
00393475372316
+81587557251
0562971361
+81-47-372-3501
81155650102
+81-11-771-5660
+81-6-6992-1001
048-536-1366
+81-42-341-2711
0339391191
+81-92-811-1821
+81-88-837-3000
81985244181
+81-6-6645-3821
+81-3-3300-5231
073-441-0659
+81236312315
+6421963555
+48604116632
+48600-107-410
+48608888796
+48503642588
+48609673001
602305132
+40721243869
0040745974029
0040731581100
+40727818190
0040757243543
0040723671301
+40749156565
+40723652564
0040723725815
+421903625643
+46(0)8-12341043