Trial Outcomes & Findings for Rehabilitation Study in MS Patients (NCT NCT00780455)

NCT ID: NCT00780455

Last Updated: 2015-05-29

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 4 participants
• Primary outcome timeframe: Up to 6 minutes
• Results posted on: 2015-05-29

Participant Flow

Only 4 patients enrolled / 70 patients planned. Study stopped prematurely

Participant milestones

Measure	Interferon Beta-1b, FRP Within 15 Days After Randomization Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.	Interferon Beta-1b, FRP About 6 Weeks After Randomization Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
Overall Study STARTED	2	2
Overall Study COMPLETED	2	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rehabilitation Study in MS Patients

Baseline characteristics by cohort

Measure	Interferon Beta-1b, FRP Within 15 Days After Randomization n=2 Participants Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.	Interferon Beta-1b, FRP About 6 Weeks After Randomization n=2 Participants Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.	Total n=4 Participants Total of all reporting groups
Age, Continuous	39.5 years STANDARD_DEVIATION 16.3 • n=5 Participants	45 years STANDARD_DEVIATION 15.6 • n=7 Participants	42.3 years STANDARD_DEVIATION 13.4 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 minutes

Population: Due to the very low number of patients enrolled in the study, no statistical report was done.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 6 minutes

Population: Due to the very low number of patients enrolled in the study, no statistical report was done.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 6 minutes

Population: Due to the very low number of patients enrolled in the study, no statistical report was done.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 6 minutes

Population: Due to the very low number of patients enrolled in the study, no statistical report was done.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At MR2 visit (6 weeks after MR1 visit) and MR3 visit (12 weeks after MR1 visit)

Population: Due to the very low number of patients enrolled in the study, no statistical report was done.

Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1. This outcome was only measured on patients in the group "Interferon beta-1b, FRP within 15 days after randomization".

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At baseline and 12 weeks after MR1 visit

Population: Due to the very low number of patients enrolled in the study, no statistical report was done.

The isokinetic evaluation analyses the flexor/extensor ratio at different rates. The evaluation will be done at the beginning on the best clinical side otherwise on the strongest. Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At baseline and 12 weeks after MR1 visit

Population: Due to the very low number of patients enrolled in the study, no statistical report was done.

Posturography protocol: Static equilibrium performances are evaluated in the standing patient on a fixed platform, in the standardized position (arms dangling, feet open at 30° and malleolus at a 5 cm distance). Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At MR2 visit (6 weeks after MR1 visit) and MR3 visit (12 weeks after MR1 visit)

Population: Due to the very low number of patients enrolled in the study, no statistical report was done.

Posturography protocol: Static equilibrium performances are evaluated in the standing patient on a fixed platform, in the standardized position (arms dangling, feet open at 30° and malleolus at a 5 cm distance). Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1. This outcome was only measured on patients in the group "Interferon beta-1b, FRP within 15 days after randomization".

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline to 12 weeks after MR1 visit

Population: Due to the very low number of patients enrolled in the study, no statistical report was done.

FSS is an auto-questionnaire estimating the fatigue. It includes 9 questions on 7 points as well as an analogical visual scale estimating the state of fatigue over the last two weeks. Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline to 12 weeks after MR1 visit

Population: Due to the very low number of patients enrolled in the study, no statistical report was done.

SEP (Sclérose en plaques) - 59: auto-questionnaire, multidimensional investigating the felt health. It contains a generic part SF (Short Form) 36 constituted by 36 items including the main concepts of quality of life and a specific part to the MS which investigates the dimensions susceptible to be degraded. 59 items are grouped in 16 dimensions: physical activity, limitations bound connected to the physical health, to the mental health, the social well-being, the pain, the energy, the emotional well-being, general Health, distress, cognitive function sexual function/satisfaction, well-being general, sleep and social support. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1.

Outcome measures

Outcome data not reported

Adverse Events

Interferon Beta-1b, FRP Within 15 Days After Randomization

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Interferon Beta-1b, FRP About 6 Weeks After Randomization

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Interferon Beta-1b, FRP Within 15 Days After Randomization n=2 participants at risk Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.	Interferon Beta-1b, FRP About 6 Weeks After Randomization n=2 participants at risk Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
General disorders Fatigue	50.0% 1/2 • Number of events 1	50.0% 1/2 • Number of events 1
Ear and labyrinth disorders Otitis external ear	0.00% 0/2	50.0% 1/2 • Number of events 1
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/2	50.0% 1/2 • Number of events 1
Blood and lymphatic system disorders Neutropenia	50.0% 1/2 • Number of events 1	0.00% 0/2
Psychiatric disorders Mood trouble	50.0% 1/2 • Number of events 1	0.00% 0/2
Hepatobiliary disorders Biliary colic	0.00% 0/2	50.0% 1/2 • Number of events 1
Eye disorders Visual acuity reduced	50.0% 1/2 • Number of events 1	0.00% 0/2
Infections and infestations Urinary tract infections	0.00% 0/2	50.0% 1/2 • Number of events 1
General disorders Tooth Extraction	50.0% 1/2 • Number of events 1	0.00% 0/2
Infections and infestations Influenza	50.0% 1/2 • Number of events 1	0.00% 0/2

Additional Information

Medical Affiars Therapeutic Area Head

Bayer Healthcare AG

Email: clinical-trials-contact@bayerhealthcare.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place