Trial Outcomes & Findings for Six Versus Two Weeks Treatment With Doxycycline in Lyme Neuroborreliosis (NCT NCT02553473)

NCT ID: NCT02553473

Last Updated: 2024-01-23

Results Overview

Clinical change on composite clinical score (CCS) defined as score at inclusion minus score at 6 months after treatment.CCS consisted of 32 variables,scored from 0 to 2 points.Minimum 0 points,maximum 64 points.High scale score indicated worse outcome. Variables scored:Malaise,Fatigue,Headache,Neck and/or back pain,Abdominal and/or breast pain,Arm pain,Leg pain,Generalised pain located to joints and/or muscles,Memory and/or concentration problems,Other,Facial palsy,Paresis of the eye muscles,Reduced hearing,Other cranial neuropathies,Cervical radicular sensory findings,Cervical radicular paresis,Thoracic radicular sensory findings,Lumbar radicular sensory findings,Lumbar radicular paresis,Non-radicular sensory findings,Non-radicular paresis,Other,Central findings in one extremity,Central findings in a hemi pattern,Central findings in both legs,Central findings in all extremities,Gait ataxia,Dysphasia/aphasia, Nystagmus,Involuntary movement including tremor,Cognitive impairment,Other.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 121 participants
• Primary outcome timeframe: Six months after end of treatment.
• Results posted on: 2024-01-23

Participant Flow

Participant milestones

Measure	Doxycycline for 6 Weeks Doxycycline 200 mg once daily for six weeks Doxycycline	Doxycycline for 2 Weeks + Placebo Doxycycline 200 mg once daily for two weeks + placebo for four weeks. Doxycycline Placebo
Overall Study STARTED	61	60
Overall Study COMPLETED	54	55
Overall Study NOT COMPLETED	7	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Six Versus Two Weeks Treatment With Doxycycline in Lyme Neuroborreliosis

Baseline characteristics by cohort

Measure	Doxycycline for 6 Weeks n=61 Participants Doxycycline 200 mg once daily for six weeks Doxycycline	Doxycycline for 2 Weeks + Placebo n=60 Participants Doxycycline 200 mg once daily for two weeks + placebo for four weeks. Doxycycline Placebo	Total n=121 Participants Total of all reporting groups
Age, Continuous	55 years STANDARD_DEVIATION 15 • n=5 Participants	58 years STANDARD_DEVIATION 12 • n=7 Participants	56 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	25 Participants n=7 Participants	54 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	35 Participants n=7 Participants	67 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	61 Participants n=5 Participants	60 Participants n=7 Participants	121 Participants n=5 Participants
Region of Enrollment Norway	61 Participants n=5 Participants	60 Participants n=7 Participants	121 Participants n=5 Participants

PRIMARY outcome

Timeframe: Six months after end of treatment.

Population: Intention to treat

Clinical change on composite clinical score (CCS) defined as score at inclusion minus score at 6 months after treatment.CCS consisted of 32 variables,scored from 0 to 2 points.Minimum 0 points,maximum 64 points.High scale score indicated worse outcome.

Variables scored:Malaise,Fatigue,Headache,Neck and/or back pain,Abdominal and/or breast pain,Arm pain,Leg pain,Generalised pain located to joints and/or muscles,Memory and/or concentration problems,Other,Facial palsy,Paresis of the eye muscles,Reduced hearing,Other cranial neuropathies,Cervical radicular sensory findings,Cervical radicular paresis,Thoracic radicular sensory findings,Lumbar radicular sensory findings,Lumbar radicular paresis,Non-radicular sensory findings,Non-radicular paresis,Other,Central findings in one extremity,Central findings in a hemi pattern,Central findings in both legs,Central findings in all extremities,Gait ataxia,Dysphasia/aphasia, Nystagmus,Involuntary movement including tremor,Cognitive impairment,Other.

Outcome measures

Measure	Doxycycline for 6 Weeks n=53 Participants Doxycycline 200 mg once daily for six weeks Doxycycline	Doxycycline for 2 Weeks + Placebo n=52 Participants Doxycycline 200 mg once daily for two weeks + placebo for four weeks. Doxycycline Placebo
Difference in Composite Clinical Score From Inclusion to Six Months After Ended Treatment	6.4 units on a scale Interval 5.6 to 7.2	6.4 units on a scale Interval 5.5 to 7.2

Adverse Events

Doxycycline for 6 Weeks

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Doxycycline for 2 Weeks + Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anne Marit Solheim, MD

Sørlandet hospital HF

Phone: 0047 38 07 39 10

Email: anne.marit.solheim@sshf.no

Results disclosure agreements

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